Radiation Therapy Program, Vancouver Island Centre, BC Cancer Agency, Vancouver, BC, Canada.
Support Care Cancer. 2012 Jul;20(7):1515-24. doi: 10.1007/s00520-011-1240-7. Epub 2011 Aug 17.
The purpose of this study is to assess the effect of topical amitriptyline, ketamine, and lidocaine (AKL) on alleviation of neuropathic pain from radiation dermatitis and the feasibility of a randomized trial.
Eligible subjects had radiation dermatitis with dry or moist desquamation with neuropathic pain and were intolerant or allergic to standard intervention. AKL was applied to painful sites three times a day daily until 2 weeks post-radiotherapy. Subjects were monitored every 2-5 days during radiotherapy and at 2 and 6 weeks after completion of radiotherapy. The University of Washington Neuropathic Pain Scale was used to grade the neuropathic pain before and after use of the interventional gel. Compliance was assessed by asking subjects at each visit how frequently they were using the interventional gel.
Over a 14-month period, 16 subjects met eligibility criteria. Eighty-two percent of subjects used the AKL as directed. Five subjects (32%) reported fatigue, and three subjects (19%) reported site irritation from the interventional gel. AKL was shown to significantly reduce (p < 0.05) pain intensity, sharpness, burning, sensitivity, itchiness, unpleasantness, deepness, and surfaceness levels on a short-term basis (i.e., between pre-treatment and 30 min post-treatment). AKL was shown to significantly reduce (p < 0.05) burning levels on a long-term basis (i.e., between pre-treatment and 2 weeks post-treatment).
AKL was a safe intervention to use with minimal toxicity and good compliance. It significantly reduced several measures of neuropathic pain associated with radiation dermatitis. A larger-scale study would require recruitment from multiple centers.
本研究旨在评估局部应用阿米替林、氯胺酮和利多卡因（AKL）对缓解放射性皮炎所致神经病理性疼痛的效果，以及进行随机试验的可行性。
符合条件的受试者患有放射性皮炎，表现为干性或湿性脱屑伴神经病理性疼痛，且对标准干预措施不耐受或过敏。AKL 每日涂抹于疼痛部位 3 次，直至放疗后 2 周。在放疗期间以及放疗结束后 2 周和 6 周，对受试者进行监测。使用华盛顿大学神经病理性疼痛量表在使用干预性凝胶前后对神经病理性疼痛进行分级。通过询问每个就诊时的受试者，评估其使用干预性凝胶的频率来评估依从性。
在 14 个月的时间里，16 名受试者符合入选标准。82%的受试者按规定使用 AKL。5 名受试者（32%）报告疲劳，3 名受试者（19%）报告干预性凝胶部位刺激。AKL 可显著降低（p < 0.05）短期（即治疗前与治疗后 30 分钟之间）疼痛强度、锐度、烧灼感、敏感度、瘙痒感、不愉快感、深度和表面感水平。AKL 可显著降低（p < 0.05）长期（即治疗前与治疗后 2 周之间）的烧灼感水平。
AKL 是一种安全的干预措施，毒性极小，依从性好。它可显著减轻与放射性皮炎相关的几种神经病理性疼痛。需要从多个中心招募更多患者开展更大规模的研究。
